# K130263: Sterrad 50/100S/200 Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Mar 28, 2014 after 417 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K042450 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051643: Sterrad Sterilizer Cyclesure Test Pack, Advanced Sterilization Products (2005) Summary page 4.
- K071537: Sterrad 100NX Test Pack, Advanced Sterilization Products (2007) Summary page 1.

## Indications for use
The STERRAD® 50/100S/200 Test Pack is used for routine monitoring of the STERRAD® 50, STERRAD® 100S and STERRAD® 200 Sterilizers and is also used for the periodic testing of these sterilizers using hospital-defined loads containing devices that do not exceed claims of the cycle. The STERRAD® 50/100S/200 Test Pack consists of the following components: * STERRAD® CYCLESURE® 24 Biological Indicator (REF 14324) * Test Pack vial with "STERRAD® 50/100S/200" marking and a corresponding cap * STERRAD® Instrument Mats (REF 99205) * Tyvek® Pouch with STERRAD® Chemical Indicator (REF 12340)

Source page: https://510kreport.com/device/K130263
Methodology: https://510kreport.com/methodology